MiniFess Maxilary Seeker 135 Degree - The MiniFESS Maxillary Seeker is a reusable, - ENTELLUS MEDICAL, INC.

Duns Number:017283879

Device Description: The MiniFESS Maxillary Seeker is a reusable, stainless steel surgical instrument used to p The MiniFESS Maxillary Seeker is a reusable, stainless steel surgical instrument used to probe within the sinuses using a trans-nasal approach. The seeker has a 135 degree bend.

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More Product Details

Catalog Number

-

Brand Name

MiniFess Maxilary Seeker 135 Degree

Version/Model Number

MS-135

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LRC

Product Code Name

Instrument, Ent Manual Surgical

Device Record Status

Public Device Record Key

560b84f5-77d9-4cb2-be68-b368ddbe92ea

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

September 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENTELLUS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 27